Intelligent Pills: A new ‘dawn’ in healthcare?

By Matt James

Have you ever been faced with the problem of trying to remember to take your medication on a regular basis? If yes, then your problems may well be over according to a new breakthrough announced this year.

In January the pharmaceutical company, Proteus Biomedical, managed to capture the attention of many of the UK newspapers with the announcement that later this year it would be launching a digital health product in collaboration with Lloyd’s Pharmacy.

Seeking to perhaps brand the launch as a ‘new dawn in healthcare’ this new product is called Helius – the name given to the personification of the sun in Greek mythology – and promises to revolutionise our relationship with taking medication. A form of “intelligent pill” Helius contains sensors which can monitor medication use. The thinking behind this idea is founded upon the fact that compliance with doctors’ instructions has been identified as a key problem in medicine and healthcare. The World Health Organisation (WHO) estimates that 50 percent of patients do not take their medications correctly whilst the NHS report that the annual cost of unused medication is estimated to be up to £400 million.

The problem is compounded further for those patients who may be prescribed a series of drugs which need to be taken at different times. Moreover, with us all waking up to the profound implications that an ageing population represents in terms of healthcare provision, you can certainly begin to understand and appreciate the thinking behind the Helius’ system.

How do intelligent pills work?

The Helius systems works on the basis of ‘ingestible event markers’ (IEM) that can either be incorporated into pills or placed into medicines as part of the manufacturing process. In this system, the sensors will be embedded in a placebo to be taken alongside a medicine. Lloyds Pharmacy hopes to make the system, which will be marketed to people with chronic conditions, available from September.

Once the person has ingested the intelligent pill in exactly the same way they would do for another other pill, the pill is activated by stomach acid and are powered in much the same way as many of us would have learnt about the basics of electrical current when making ‘potato batteries’. A current is generated between two different metals when inserted into the potato. In the case of Helius each sensor on the pill contains a tiny amount of the metals copper and magnesium and our bodies are the potato. The current which is produced powers the device to create the signal, which can only be detected by the device which is attached to the patient’s skin in the same way as a bandage would be. Consequently, the pill does not work on RFID technology but rather uses the conductive tissues of the body to conduct the signal, rather than a radio, and the signal is confined within the body[1].

The range of data which can be tracked and monitored includes heart rate, respiration and temperature, showing how the patient responds to the medication. In turn, the data generated can then be relayed to a patient’s mobile telephone – another key element in the product’s development – and monitoring, tracked and shared accordingly. Hearing CEO Andrew Thompson speak at a Royal Academy of Engineering event in November 2011 on Helius, he explained how the fact that the poor rates of compliance and access to the mobile telephone had inspired the development of the product. It is reported that there are 5.9 billion mobile subscribers in the world today[2]. That’s 87 percent of the world’s population who has access to a mobile. It therefore sounds like an inspired idea to harness this existing technology in order to innovate and provide a solution to a pressing problem.

The system has undergone quite an extensive period of testing, including various trials patients in many different therapeutic areas. It has been tested in tuberculosis, in mental health, in heart failure, in hypertension and in diabetes.

Is it as cutting edge as it seems?

Whilst the idea of ingesting an intelligent pill might seem very new and cutting edge, once again, the basic idea has been around for a while now. Back in the 1980s, NASA developed ingestible thermometers in the 1980s to measure astronauts’ core temperatures. These thermometers have lately been adopted by some athletes. Other researchers have created cameras in pills to image the digestive system from the inside[3]. But clearly this represents a bit of a watershed moment as the product comes onto the open mass market.

The term “compliant” implies a sense of obeying and obliging, especially in a submissive way and it this sense of the patient being controlled which Helius seems to want to address. By putting the power into the hands of patient, the system promises to allow the patient to better manage their own care and medication and empowered to be responsible for their own care. “What we know is that we’ve created many pharmaceuticals with great potential but much of that potential is not realised because these drugs are not being used properly,” said CEO Andrew Thompson[4] . A further step along the path of personalised medicine?

Surely this kind of technology must be celebrated as a significant breakthrough? In many respect it is marvellous to see how this kind of technology could improve healthcare and allow patients to be better informed about their own health. With ‘disruptive innovation’ being one of the buzz phrases of the age, Helius seems to be in the vanguard of demonstrating how smart pills, wireless networks and mobile phones can converge in order to create improve a healthcare service in an unexpected way.

Introducing some form of sensor into the body presents some interesting questions which need careful consideration at this point in time. The Helius system being showcased by Proteus will more than likely be the start of something, helping to flag up what the future may hold in 10–20 years time. The possibilities that this kind of technology offers us could take us in some various interesting directions in the future.

In broadly welcoming this new kind of technology, I think we need to consider the following points:

Does this maximise the human experience?

Whilst perhaps not the first issue which springs to mind this form of technology could be viewed as a form of human enhancement. It is not necessarily giving us any new form of capabilities such as infra red communication capabilities. Nor is it a ‘smart drug’ affording those suffering from diseases, such as ADHD and Alzheimer’s, significant therapeutic value and for other users short–term gains in concentration and mental functioning. But these ‘intelligent pills’ is affording us the capability of tracking data on the inner workings of the human body and thereby informing us more readily. Functioning which has already existed but which we are more acutely aware of.

So I suppose the question remains, is this a form of enhancement technology which maximises the human experience or takes us beyond human? In many respects, is this just a more ‘high tech’ version of a barium meal, the procedure in which radiographs of the oesophagus, stomach and duodenum are taken after barium sulphate is ingested by the patient?

In 2004 the European Union’s High Level Expert Group produced a report entitled “Converging Technologies for the European Knowledge Society” which was more of a philosophical document in comparison to the US National Science Foundation’s more visionary, ‘blue sky thinking’ report of 2001. Essentially the EU report argued that there should not be “engineering of the mind and of the body” but rather “engineering for the mind and for the body”, somehow maximising our humanity without taking us beyond it. Whilst helpful, critics have attacked this distinction due to the fact it presupposes that a neat distinction can be made between peripheral technologies – external tools that may augment function and the underlying hardware.

At the moment I do not think this does take up beyond human but helps to maximise the human experience and the duty to heal. But certainly into the future there is certainly the scope for more significant advances in this area. Application of nanotechnology is significantly helping to improve drug solubility and targeted drug delivery in the body. Recent report report that it will grow from a current value of $2.3 billion to $136 billion by the year 2021[5] . Based on advances in nanotech and the emergence of the intelligent pill you could begin to imagine us taking a step closer to a scenario resembling the world of nanobots operating the length of the body, carrying out targeted, routine maintenance and being monitored and controlled remotely by medical teams. Are we ready for this kind of possibility? Depending on our answer, what do we need to be doing now to prepare for it or an alternative more acceptable outcome?

Safety

Whilst the role of the mobile telephone is an novel and innovative way of harnessing existing technology, concerns have been expressed over the long term of mobile phones, particularly with regard to Bluetooth technology. Proponents of the intelligent pills are quick to point out that rather than using radio frequency identification devices (RFIDs) the signal is transmitted electrically through skin tissues. Thus, the signal could not be intercepted by other users.

At present there are no extensive studies regarding the system’s safety and so it would to assess the technology against such studies. True, there appears to be three years of ethnographical work – human data – showing that the technology works. This includes a pilot project the company undertook with Novartis using 20 patients on Diovan for high blood pressure. Results showed that compliance improved from 30% to 80% after six months[6]. Yet with specific regard to safety there seems to be sparse information. In order to allay fears and critics, this needs to be addressed.

Being a US based company, Proteus has brought the product before the Food and Drug Administration (FDA) for approval which it subsequently gave without tests for safety. In the approval letter the FDA stated that it has:

determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labelling, and prohibitions against misbranding and adulteration[7] .

As Jonathan Cooper, a biomedical–engineering researcher at the University of Glasgow, Scotland, and founder of the medical company Mode Diagnostics, points out at the same time as steps are taken to increase functionality so must the demand for more power increase. Thus, the pill becomes larger and the larger the pill the more problems could arise within the body such as pills become lodged in the digestive tract[8] . In much the same way as there remains a lot of unanswered questions concerning toxicity and the behaviour of nano particles in the body, there probably remains a need for long term monitoring of the effects of intelligent pills on the body, if only to check that what is believed to be the case now, remains so.

Privacy

This is perhaps the key question which arises most readily in people’s minds when the discussion covers issue of data generating and rightly so. Already the critics are saying that individual rights are being ridden rough shod over. Clearly matters of privacy are important and will remain so as new technologies develop. In the specific case of Helius, patients and families should be aware of the full range of data being generated and who it will be accessed by. Proteus adds that security safeguards would be used to protect transmitted data[9] .

Similar issues arise with this technology as they do with biometrics and other forms of new technologies which help to identify us and in so doing offer the opportunity to challenge our freedom and dignity. Much of the marketing and publicity from Proteus speaks of the intelligent pills empowering the patient and not the professional, placing them at the heart of the design process. However, where will the lines of engagement and responsibility be drawn in terms of data usage and storage? Certainly having the range of data available to patients offers the potential of informed decision making but could it also creep to empowering other professionals to start dictating what an individual can or cannot eat, activities which they can or cannot undertake or places they cannot or cannot visit, on the grounds of data which supports their advice. In the same way those specific groups can be identified for good, could it be used to discriminate against certain groups?

Whilst not wishing to vilify ‘big pharma’ unnecessarily, one cannot fail to see the lucrative incentives which this kind of intelligent pill could offer both the pharma and health insurance industry. Where the pharma industry currently lose many billions of dollars in sales from patients on long–term prescriptions who do not take their pills, being able to track the patient’s medication would be a significant help in saving money. Likewise, health insurance companies could stand to gain the advantage and potentially decline insurance cover on the knowledge of whether the patient has or has not kept up to date with taking their medication.

Clearly the long term success of this kind of technology must hinge on trust and accountability. We must not forget that all kinds of data is being generated, mined and stored already from all manner of different sources. This does not mean that we should take a laissez faire attitude towards it. Rather we need to readily engage and decide how this data is handled, entering into a trust relationship with those holding the data based on trust, choosing to use it in a way that empowers us rather than controls and inhibits us. This is far easier said than done, giving the many examples of failed IT projects or data breaches which have hit the headlines. But whether we like it or not, this in many respects defines life today. Data generation is part of our lives now, we need to acknowledge and start engaging with the implications today.

Thus we return to Proteus’ message of ‘power to the patient’. Yet building on the trust concept and crucial to Helius’ long term success must be how data is managed and stored so that it is not used without our knowledge. As this empowered patient which Helius seeks to help us become, we need to ask ourselves how prepared are we for public disclosure of our information to become more apart of our daily lives? The man behind Google, Eric Schmidt, is famously quoted as saying, “If you have something that you don’t want anyone to know, maybe you shouldn’t be doing it in the first place” and sparked fierce debate. The Electronic Frontier Foundation responded: “Google, governments, and technologists need to understand more broadly that ignoring privacy protections in the innovations we incorporate into our lives not only invites invasions of our personal space and comfort, but opens the door to future abuses of power.”

These questions may well help to determine whether the developments Proteus and others are affording us point to the future of a bright new dawn or a dazzling but rude awakening.